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FDA 510(k)

空气压缩腿部按摩器(型号:S9036C, S9036B和S9036A)

K号: K222206 · 2022-09-30

决定日期2022-09-30
产品代码IRP
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决定实质等同

器械摘要

Air Compression Leg Massager (Models: S9036C, S9036B and S9036A) is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Dongjilian Medical Tech Co., Ltd.. It received FDA 510(k) clearance on 2022-09-30 under 510(k) number K222206. The device is classified under product code IRP. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Air Compression Leg Massager (Models: S9036C, S9036B and S9036A)?

Air Compression Leg Massager (Models: S9036C, S9036B and S9036A) is a medical device that received FDA 510(k) clearance on 2022-09-30. The listed applicant is Shenzhen Dongjilian Medical Tech Co., Ltd.. The 510(k) number is K222206.

When did Air Compression Leg Massager (Models: S9036C, S9036B and S9036A) receive FDA 510(k) clearance?

Air Compression Leg Massager (Models: S9036C, S9036B and S9036A) received FDA 510(k) clearance on 2022-09-30, under 510(k) number K222206.

Who is the listed applicant for Air Compression Leg Massager (Models: S9036C, S9036B and S9036A)?

The FDA 510(k) record lists Shenzhen Dongjilian Medical Tech Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Air Compression Leg Massager (Models: S9036C, S9036B and S9036A)?

The FDA product code for Air Compression Leg Massager (Models: S9036C, S9036B and S9036A) is IRP.

相关临床试验

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系;请查阅链接的官方来源。

列明Shenzhen Dongjilian Medical Tech Co., Ltd.为申报人的其他记录

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系;请查阅链接的官方来源。

相关器械(代码:IRP)

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系;请查阅链接的官方来源。

官方来源

在 FDA 数据库中查看 →

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